HYDROXYCUT PRODUCT SIDE EFFECT AND DANGERS - FDA WARNING STOP USING THIS PRODUCT
Hydroxycut products are dietary supplements that are marketed for weight loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.
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FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA.
Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.
Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
FDA urges consumers to stop using Hydroxycut products in order to avoid any undue risk, says Linda Katz, M.D., interim chief medical officer of FDA's Center for Food Safety and Applied Nutrition. "Adverse events are rare, but exist," Katz says. "Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products.
The list of products being recalled by Iovate currently includes:
- Hydroxycut Regular Rapid Release Caplets
- Hydroxycut Caffeine-Free Rapid Release Caplets
- Hydroxycut Hardcore Liquid Caplets
- Hydroxycut Max Liquid Caplets
- Hydroxycut Regular Drink Packets
- Hydroxycut Caffeine-Free Drink Packets
- Hydroxycut Hardcore Drink Packets (Ignition Stix)
- Hydroxycut Max Drink Packets
- Hydroxycut Liquid Shots
- Hydroxycut Hardcore RTDs (Ready-to-Drink)
- Hydroxycut Max Aqua Shed
- Hydroxycut 24
- Hydroxycut Carb Control
- Hydroxycut Natural
Consumers who have these products are advised to stop using them and to return them to the place of purchase. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts.
Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.
Online: Medwatch Reporting
Regular Mail: Use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects
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This article appears on FDA's Consumer Update page, which features the latest on all FDA-regulated products.
Date Posted: May 1, 2009
A new study has linked a number of popular dietary supplements to adverse hepatic reactions including acute liver injury and other serious side effects. Significant injuries have been reported following the consumption of Herbalife and Hydroxycut products, green tea, supplements containing usnic acid and high contents of vitamin A, as well as in anabolic steroids and others. The side effects associated with these products vary widely from person to person, ranging from elevated serum liver enzymes to hepatic failure and even death.
Free Dietary Supplement Liver Injury Case Evaluation: If you or a loved one has suffered a serious liver injury after consuming dietary supplement products, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
What’s the problem?Over the past decade, the use of dietary supplements (DS) has become a major health trend in the United States and other affluent nations. Between 1999 and 2004, consumption of dietary supplements in the US doubled to nearly 20 percent of adults and upwards of 50 percent in certain subgroups such as among elderly, non-smoking females with higher education. This dramatic rise in popularity of dietary supplements can largely be attributed to an increased health conscious awareness and the desire to prevent diseases by optimal nutrition. As a result, the manufacturing and marketing of DS products has become a multibillion dollar business largely unregulated by the U.S. Food & Drug Administration (FDA).
In the United States, dietary supplements are expected to meet standards outlined in the Dietary Supplement and Health Education Act, which allows DS distribution without prior approval by the FDA. This controversial licensing practice does not ensure efficacy and safety in the same strict way as with the approval process of conventional drugs. The reckless approval of dietary supplements is made even more troubling by the fact that DS may harbor specific problems because of their complex composition, particularly with respect to quality aspects.
While a number of side effects associated with dietary supplements have been well documented, the issues at hand are still not clearly understood due to widespread and uncontrolled use, as well as by the under-reporting of side effects. Making matters worse, a low public awareness regarding the risk of DS products impedes their recognition as the causative agent in incidents of hepatoxicity. Consequently, statistics involving dietary supplement side effects are likely inaccurate and too low.
Dietary Supplement Liver Injury Case StudyA recent article published in the Official Journal of the International Association for the Study of the Liver has reviewed the current medical literature on liver injuries associated with dietary supplements in order to identify the mechanisms of injury and to increase public awareness of the risks posed by these popular products.
In February 2010, case reports on liver injury occurring following the consumption of dietary supplements published between 1990 and 2010 were searched in PubMed and EMBASE databases and critically reviewed. Products were considered dietary supplements if they were intended to be consumed to improve nutrition, lose weight, or to treat constipation. While hepatoxicity from DS has been addressed in previous case studies, there were few if any summaries devoted specifically to liver-related risks. The new article, which is titled ‘Review of liver injury associated with dietary supplements,’ reviewed a panel of best-selling dietary supplements that have been associated with acute liver injury.
Herbalife Liver Injury Side EffectsHerbalife sells a variety of dietary supplement products for weight control, nutrition, ‘well-being’ and cosmetics. In 2006, it was reported that the company generated $3.1 billion in profits via online marketing and independently operating sales agents.
Since 2007, there have been six published reports on liver damage following the consumption of Herbalife products. Cumulatively, the reports described 34 cases from five countries – Switzerland, Israel, Spain, Argentina and Iceland. The pattern of injury was mostly hepatocellular, but mixed and cholestatic enzyme patterns were also observed. Severity of side effects ranged from mild to severe hepatic damage, including cirrhosis and acute liver failure requiring liver transplantation.
It still remains unclear what might have caused the liver damage in these cases, as patients took up to 17 different Herbalife products at the same time, making it extremely difficult if not impossible to identify the critical compound(s). Moreover, speculations flew over potentially adultered Herbalife products after two patients demonstrated bacterial contamination as a possible explanation of liver injury. Herbalife has numerous manufacturing facilities worldwide, suggesting that contaminated products either intentionally added during the manufacturing process or accidentally contained in the unrefined raw products could have been responsible for the reports of hepatoxicity.
Green Tea (Camellia Sinensis)Green tea is among the most popular dietary supplement drinks in the United States today. The first incidence of liver injury associated with green tea was reported in 1999, and since then, a rash of similar cases have been reported to regulatory agencies worldwide. In response, a number of green tea manufacturers have recalled their products from their respective markets.
The US Pharmacopeia performed a systemic review of all cases accessible from PubMed, EMBASE and various pharmacovigilance databases, and found a strong causal relationship between observed liver injuries and green tea consumption. The mode of toxicity derived from green tea still remains incompletely understood, but experimental studies have demonstrated both hepatoprotective as well as hepatotoxic properties.
‘Whether the risks from green tea consumption outweigh their benefits remains open, but current evidence as outlined above suggests a causal relationship between intake of green tea containing products and hepatoxicity.’
Hydroxycut Liver InjuriesHydroxycut is designed to support weight loss, and is sold in powder, capsule, and tablet formulations. Several Hydroxycut drugs have recently been recalled by Lovate Health Sciences following a May 2009 warning issued by the FDA citing 23 reports of severe liver injury associated with the products. Lovate has been charged previously with several lawsuits for unfounded health claims.
Before 2009, Hydroxycut’s main ingredients included Garcinia cambogia, Gymnema sylvestre, chromium polynicotinate, caffeine and green tea. Published cases were recently reviewed and showed acute onset of liver injuries after several weeks of
Although its exact frequency remains unclear, hepatic injury secondary to consumption of dietary supplements like Herbalife, green tea and Hydroxycut is recognized. Apart from enhanced diagnostic measures, better regulatory steps to assure efficacy are required. Efforts of pharmacovigilance authorities and healthcare providers must act jointly to minimize risks and protect the public. Perhaps most importantly, consumers should develop a more critical attitude toward the expectations and hopes associated with dietary supplement use, and turn to measures for which safety data are known and efficacy is proven.
Do You Have a Dietary Supplement Liver Injury Lawsuit?The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in dietary supplement liver injury lawsuits. We are handling individual litigation nationwide and currently accepting new dietary supplement liver injury cases in all 50 states.
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MOST POPULAR SPORTS SUPPLEMENT BANNED
There are two comments bound to make any credible herbalist cringe. One is "It can't hurt me, it's all natural," and the other is "herbs don't have any side effects or interactions." Both are wrong. They can hurt you and they do have side effects and interactions.
Dangerous Herbs: Two good examples in this category are Ephedra and Blue Cohosh. Ephedra has often been used in weight loss products. It was once banned but seems to now be in some sort of grey area. The problem is that it could kill you. The substance in it is chemically similar to epinephrine, and it could cause a heart attack, amongst other things.
Blue cohosh is sometimes recommended to speed childbirth. The good news is that it can do just that. The bad news is that both mother and child could die before the baby is even born. Infants have been born having heart attacks because their mother took blue cohosh.
Cautionary Herbs: Some herbs may be effective, but the number of side effects, interactions or preparation methods makes herbalists nervous unless properly prepared. Cherry bark is great for stopping a cough, but it isn't something for those who don't know how to prepare it to work with. The principle that helps stop the cough is cyanide, and too much of that will kill you.
Licorice is another good example. The problem here are the side effects and interactions. The root is high in sugar, so it could cause problems in diabetics. It raises blood pressure, so it could cause problems for those with high blood pressure or heart disease. In fact, it can cause heart rhythm problems in healthy people.
GRAS: This acronym stands for "generally recognized as safe." While these herbs do have side effects and interactions, most people can take them safely. Chamomile, garlic, lemon balm and so forth are all on this list.
There are three ways herbs can have a major effect on your body. Knowing the herb and what these terms mean may help you make the right decision.
Interaction: This problem happens when two things are combined that react to each other. If you've ever done the "volcano" experiment, you've seen one outside your body. If you mix vinegar and baking soda, it will foam up. Some herbs do that inside the body, both with other herbs and with medications. While this is all right on occasion, most of the time interactions are not considered good things.
Side Effects: The main action of chamomile is to help calm a person down. One of the side effects is it makes that person sleepy. Another is that it could cause uterine contractions. These side effects can be a problem if you're driving somewhere or you're pregnant. That's what a side effect is; something other than the main reason you're taking the supplement.
Medical Conditions: Conditions such as diabetes, heart disease and immune function diseases can all react negatively to certain herbs. I've already mentioned licorice, which covers the first two. When it comes to the immune system, another popular herb is a problem. It is not advised to take Echinacea if you have any problem that affects that system.
Choosing the right supplement is not like picking out a new pair of shoes. Talk to your doctor, your pharmacist and if possible a qualified herbal practitioner. We may be able to help you find a supplement that is right for you and doesn't do you more harm than good.
- Jack3d is mainly bought over the internet although it has been available in some sports stores
- It contains a stimulant called DMAA that could have lethal side-effects
A sports supplement popular with fitness fanatics has been banned in Britain because of fears it may have lethal side-effects.
The drink Jack3D contains a stimulant known as DMAA (dimethylamylamine) that has been linked to high blood pressure, headaches, vomiting, stroke and even a death.
The UK’s medicines watchdog MHRA (Medicines and Healthcare products Regulatory Agency) has ruled it is unlicensed and all other DMAA containing products need to be removed from the market to protect public safety.
The decision follows similar warnings around the world, including in the US and Australia where a man died after buying DMAA online.
Jack3d is said to boost energy, concentration and metabolism. But DMAA, most commonly used as a workout aid or dietary supplement, can have a physiological effect on the body by narrowing the arteries and raising the heart rate, said the MHRA.
This has been linked to suspected adverse drug reactions worldwide, ranging from shortness of breath to heart attacks.
An MHRA spokesperson said: 'Jack3d is mainly bought over the internet although it is also available in sports stores specialising in work out products.
'If we find a shop selling it we will send them a written reminder asking them to remove it from their shelves. If they ignore this then our enforcement officers will move in and begin legal action.
'It is the most popular sports supplement in the UK because it is a stimulant that allows you to work out for longer.
'But it is for people who are really into their fitness. Your average person who goes to the gym once or twice a week is unlikely to have ever used it.'
The MHRA has already issued eight urgent notices instructing retailers to remove the product and any other DMAA containing products from sale.
The MHRA has recently taken action against a number of products presented as sports supplements that fall within the definition of a medicinal product because of the potent herbal ingredients they contained.
The chemical ingredient DMAA is also on the prohibited list of banned substances by the World Anti-Doping Agency and has been responsible for 137 doping violations worldwide.
Jack3d is the most popular sports supplement in the UK because it is a stimulant that allows you to work out for longer
'We recommend people only use approved products and speak to a qualified medical practitioner if they have any concerns about any supplements they may be taking.'
Relevant companies are advised to remove Jack3D from sale and to take similar action for other products containing DMAA, which is also known by many names including Methylhexanamine, Geranamine, Geranium oil and ‘Cranesbill’.
Graham Arthur, director of Legal at UK anti-doping, added: 'This is a significant step forward for all competitive athletes as methylhexaneamine (DMAA) is a banned substance ‘in-competition’ that frequently appears in over the counter and internet bought products but not clearly on the label.
'Athletes who use sports supplements need to choose reputable manufacturers who can justify their claims with scientific evidence, and have their products screened to minimise the risk of testing positive for a substance on the World Anti-Doping Agency’s Prohibited List.
'UK Anti-Doping continues to work closely with the MHRA to protect the health of athletes and to prevent doping in sport.'
Sport Supplement Side Effects
Apr 28, 2011 | By Jennifer Nall, M.S., R.D., L.D.
The use of supplements is common practice among athletes. Many believe taking supplements will improve performance. However, not all supplements are safe, and not all supplements have been proven effective. Supplements used by athletes include ephedra, caffeine, carnitine, and creatinine. It is important to consider the positive and negative impact of using supplements before you add them to your diet.
Ephedra is the name for any dietary supplement containing ephedra alkaloids. Althletes use ephedra for weight loss and increased energy, with the goal of enhancing their performance. There is much debate over the safety of this supplement, specifically what dosage is safe. The FDA banned ephedra fora number of years on the basis that the health and safety risks were too great.Currently there is a ban on the sale of high-dose ephedrine, but doses of 10 mg or less are legal. Reported side effects include headache, rapid heart rate, increased blood pressure, and insomnia. Strokes, heart attacks and death have also been reported.
Caffeine, which is most commonly found in sodas, coffee, and energy drinks, is used to provide energy and burn fat. The primary effects of caffeine occur in the central nervous system and include increased awareness and the perception of less effort used. Side effects include increased blood pressure, increased heart rate and insomnia. In addition, sudden withdraw of caffeine by a person who regularly includes it in his diet can result in headaches.
Carnitine is needed in the body for the transport of fatty acids to mitochondria to be used for energy. It is thought that carnitine use decreases muscle pain, increases endurance, promotes weight loss, and improves cardiac function. Despite these claims, more studies are needed to confirm the benefits and potential side-effects of carnitine supplementation.
Creatine is one of the most popular sports supplements. It is used in the form of phosphocreatine by the body as a source for muscle energy. Reported benefits include increased strength, endurance, and muscle gain. While supplementation may help improve strength over time, creatine ingestion often results in weight gain, which can negatively impact performance for runners and swimmers.
"Sports Nutrition: A practice Manual for Professionals 4th edition; Marie Dunford, PhD, RD; 2006
Food and Drug Administration: Final Rule Declaring Dietary Supplements
Containing Ephedrine Alkaloids; 2000
Sport Supplement Side Effects
By Jonathan Lister, eHow Contributor
Sport Supplement Side Effects thumbnail
Many ingredients of sports supplements have not been evaluated by the FDA
Sports supplements can help athletes build muscle and increase endurance as part of a workout regimen. These supplements can have varying side effects that can affect multiple systems of the body depending on the dosage and how often supplements are consumed. Young athletes are especially encouraged to consult with a doctor before beginning a sports supplement regimen.
Digestive Tract Effects
Athletes using sports supplements take in more calories than with a traditional "three meals a day" diet. This increased caloric intake can have an adverse effect on your body's digestive tract. Diarrhea, stomach cramps and constipation can all be side effects of your body adjusting to the increased caloric intake. Most sports supplements are infused with soy protein, which can also cause digestive problems.
According to the website Kid's Health, androstenedione, a form of "natural steroid" that the body breaks down into testosterone, can cause several adverse side effects in a developing teen or adult. Large doses can cause hormonal imbalances that lead to mood swings and depression and may stunt the growth of young athletes. Other symptoms can mimic anabolic steroid use such as hair loss, increased aggression and increased risk for certain forms of cancer and heart disease.
By Peta Bee |
Yet whey, produced when milk is coagulated to make cheese, is being touted as hugely beneficial for a range of ills.
Whey powder — made when the liquid is commercially dried, and then mixed with milk or water to form a flavoured ‘milkshake’ — is currently hogging the limelight in the food supplement world, with promises it will help you lose weight, keep you mobile into older age, and result in a host of other benefits from a boosted immune system to cancer prevention.
It has traditionally been marketed to bodybuilders and is often seen in oversized tubs on the shelves of health food shops.
Now companies such as Maximuscle and the Good Whey Company are promoting it as a daily requirement not just for fitness addicts but for anyone — old and young — who wants healthy muscles and bones, and as an aid for weight loss.
The manufacturers say we begin to lose muscle mass with age — some even experience a decline from their mid-30s — and they claim sipping these whey shakes from middle age onwards can help keep us mobile into older life.
‘Exercise is crucial for creating and maintaining muscle, but feeding our muscles through a healthy diet is just as important,’ says promotional material from the Good Whey Company.
Indeed, whey is already the preferred dietary aid of the Hollywood set and many Olympic athletes.
But is whey really such a cure-all?
Some experts warn that Britons already eat too much protein and the shakes are suitable only for those taking rigorous exercise.
Whey has long been reputed to hold health benefits.
Hippocrates, the Greek father of medicine, recommended it to his patients and fashionable medical spas in Switzerland prescribed it for its healing properties in the early 19th century.
Now, taking it has become much more straightforward.
The likes of Gwyneth Paltrow are consuming whey protein shakes as part of their detox regimens
These differ slightly in their composition, but all are low in fat and easily absorbed by the body.
Commercial products tend to contain a mixture of all three types and it is these extracted proteins that are reputed to have such potent effects on health.
Certainly, much of the emerging evidence into whey’s effects seems promising.
Whey protein is high in essential fatty acids and branch chain amino acids — compounds that evidence suggests may help the body to build or maintain lean tissue, as well as boosting fat-burning, and increasing the efficiency of the immune system.
A study conducted a couple of years ago at Washington State University found drinks that contained whey protein helped lower blood pressure significantly, reducing the risk of stroke and heart disease.
Susan Fluegel, a nutritional biochemist who led the study, found daily doses of a commonly available whey product brought more than a six-point reduction in blood pressure (in some cases the levels dropped from an elevated 140/85 to a healthy 123/78).
‘It’s low cost and whey protein has not been shown to be harmful in any way,’ Ms Fluegel said.
Others have shown it may play a role in cancer prevention.
When Ohio State University food scientists treated human prostate cells with whey protein, they found that cellular levels of glutathione, known to help control cancer-causing free radicals, increased by up to 64 per cent.
Although more studies need to be done to confirm the effects, the researchers suggested regular whey protein consumption could have similar effects.
Since human prostate tissue is particularly susceptible to oxidative stress, which produces free radicals, the presence of such high levels of glutathione could help to prevent the build-up of free radicals that are often associated with both cancer and heart disease, the researchers concluded.
Whey has also been shown in some studies to have a positive effect on blood sugar in diabetics.
And a study published in the American Journal of Clinical Nutrition suggested it lowered levels of fat in the blood following a high-fat meal in overweight people, a factor that is implicated in a raised risk of heart disease.
When it comes to body-honing, whey protein can help boost muscle recovery after a workout — which can lead to an increase in muscle strength.
During exercise, muscle fibres undergo a cycle of breakdown followed by rebuilding and growth.
A study at McMaster University in Canada last year showed whey to be more effective than casein, another popular protein supplement, in boosting this process.
But the links with muscle tone and weight loss exist only when exercise is fairly intense and consistent and includes some resistance work (such as weight training), as well as aerobic work of a reasonable intensity (running or cycling with fast bursts).
Digesting protein in amounts that exceed your body’s needs will lead to weight gain.
And we already eat too much in the UK, with men typically getting 88g and women 64g of protein a day, above the recommended daily allowance (RDA) which is 55.5g for men aged 19-50 (53.3g for men aged over 50) and 45g for women aged 19-50 (46.5g for over-50s).
James Collins, the sports nutritionist for Arsenal football club and Team GB athletes, says extra whey protein can be useful for older people who are prone to loss of muscle mass through ageing — a condition called sarcopenia.
This usually starts at age 45 and results in a 1 per cent loss of muscle mass per year. But, he says, a daily dose of 25g of whey protein in supplement or shake form is all that’s needed.
‘Any more doesn’t increase protein synthesis or other benefits,’ he says.
Sports dietitian Jennifer Low, of the British Dietetic Association, says: ‘If you opt for whey protein shakes over and above your normal diet, then you will gain weight if you are not increasing the exercise you do.’
While whey protein powders are convenient, Ms Low says, you can get the benefits of whey protein from drinking milk — although you would have to consume the equivalent of 11 glasses to get the same amount of whey protein containing in one shake.
Ms Low adds: ‘Natural foods such as milk offer a complete health package of protective nutrients that you just don’t get in supplements.
'A 200ml glass of semi-skimmed milk contains 3.6 per cent protein and about 20 per cent of this is whey protein.
‘Unless you are exercising heavily, it’s unlikely you need a supplement for the beneficial effects. Whey protein powder is not a magic fix.
‘Don’t make the mistake of drinking it thinking you will transform your shape by doing so.
'Losing weight and gaining muscle tone requires effort.
'Celebrities don’t look the way they do just by drinking a daily shake.’
February 23, 2011A bill has been introduced to the Senate that would drive up the cost of dietary supplements and restrict your access to them. This bill seeks to give the FDA arbitrary control over what supplements you are allowed to have.This bill proposes to squander tax revenue, while burdening the private sector with oppressive laws that will hinder scientific advances and increase costs. The net effect will be to take away your free access to dietary supplements.Pharmaceutical interests are obviously behind this latest effort to legislatively force more Americans towards expensive prescription drugs and away from natural ways of preventing degenerative disease.
Please use our convenient legislative action center to e-mail your Senators and Representatives to protest against this dangerous piece of legislation.
(Note: This communication is not an attack on any elected official. Many Senators would have been deceived by pharmaceutical lobbyists, as you will soon read.)
The bill represents the kind of federal regulation that is not only ineffective, but also suffocates innovation in ways that inflict permanent damage to this nation’s economic vitality.
The bill supposedly originates from the controversy surrounding the use of steroids by Major League Baseball players. Since some unethical companies illegally sold steroid drugs as “dietary supplements,” certain members of the Senate appear to have been deceived into believing that the FDA needs to be given additional power to ban dietary supplements across the board.
The fact is that the FDA has all the legal authority it needs to remove supplements that contain illegal drugs from the market. The FDA has failed to do its job, and there are companies selling dietary supplements that contain prescription drugs. If the FDA continues to fail to do its job, then these companies will continue to sell drug-tainted supplements no matter what new laws are created by Congress.
The outrage over this bill expressed by so many supplement consumers is that it gives the FDA broad and arbitrary new powers to remove natural products from the marketplace. Since the FDA (and Congress) is dominated by large pharmaceutical interests, this bill will effectively enable drug companies to control which supplements you have access to.
You may recall the FDA’s ban last year of a more effective form of vitamin B6 (pyridoxamine) because a pharmaceutical company wants to have it approved as an expensive new prescription drug to treat diabetic kidney failure.
If this bill is passed, it will make it far easier for pharmaceutical companies to file use patents on what are now inexpensive dietary supplements and convert them into outrageously priced “drugs.” Just look at the cost of prescription drug fish oil that so many cardiologists are prescribing to their patients. It costs about seven times more than the same amount of EPA/DHA fish oil you can buy as a dietary supplement. Just imagine if the FDA was given arbitrary power to ban omega-3 dietary supplements!
In order to mislead the public about the true nature of this bill, it has been named the Dietary Supplement Safety Act of 2010 (DSSA). It purports to protect consumers, but the question arises, from what?
According to a published report by the American Association of Poison Control Centers, no one died in the year 2008 as a result of taking a dietary supplement.1 The facts are that legitimate reports of deaths caused by dietary supplements in this century are virtually non-existent.
Despite this safety track record, this bill would give the FDA authority to draw up a list of allowed and disallowed supplements (and supplement potencies). This alone would destroy your free access to supplements. But there is more.
There is no real world rationale for this legislation. Yet this bill would automatically cause any dietary supplement to be classified as “adulterated” if it is “manufactured, packaged, held, distributed, labeled or licensed by a dietary supplement company not registered with the Secretary.” The “Secretary” in this case is the Secretary of Health and Human Services, the department of the federal government that oversees the FDA.
The registration requirements would add layers of overhead costs to manufacturers who are already fully compliant with current Good Manufacturing Practices (cGMP) and are inspected by the FDA. It would also create an entire new category of taxpayer-funded bureaucrats who would oversee this hideous expansion of federal control over dietary supplement access.
The registration process would require paperwork to be submitted to the federal government for every new formulation, re-formulation, new ingredient, etc. The effect will be to take what are now low-cost natural supplements and force the paperwork requirements to be more closely aligned with those of unaffordable prescription drugs.
These burdensome registration requirements also mandate voluminous paperwork submissions for new ingredients that give the FDA more power to DENY the “approval” of a natural ingredient. This clause of the bill would further reduce the availability of new dietary supplements coming to the market…effectively giving pharmaceutical companies a monopoly over what new health products you are allowed to use. Any new products that make it to market will carry the higher cost associated with complying with this bill’s new obstructive mandates.
The FDA already requires manufacturers to maintain records of serious adverse reaction reports. This bill would require that all “non-serious adverse events” be submitted to the federal government. The problem is that when a large group of people take any product, there are always coincidental adverse reactions. This means that for any given product, the FDA can arbitrarily take the list of adverse reports submitted to it and use it as a basis to remove the product, even if there was not a single valid adverse reaction! Once again, pharmaceutical companies would be able, under the Freedom of Information Act, to gain access to coincidental reports of adverse reactions and petition the FDA to REMOVE the supplement from the market. (There are of course millions of cases of serious adverse reactions—including many deaths—on file with the FDA about the drugs they approve, but of course these drugs are virtually never withdrawn from the marketplace by the FDA.)
The FDA already has broad powers to remove dangerous products. This legislation would enable the FDA to ban anything if they have only “reasonable probability” that there is a serious problem with a product. This kind of discretionary authority gives the FDA tyrannical power to ban supplements, a power they have not hesitated to use when they’ve had it.
Recall that in the early 1990s, the FDA declared that many of the supplements used today, including CoQ10, selenium, and chromium, were inherently dangerous. The public’s revolt against the FDA’s absurd proclamation led to passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994. This is the law that protects consumers’ rights to access low-cost dietary supplements. The Dietary Supplement Safety Act (DSSA) would largely eviscerate the protections afforded by DSHEA.
Just imagine owning a pharmaceutical company and hearing from physicians that patients are refusing to take your expensive side effect-prone drugs. Instead you learn they are switching to low-cost dietary supplements that you cannot patent.
Since you control a large percentage of Congress, the logical solution is to have legislation enacted that will enable the FDA (that you also control) to remove supplements that compete with your drugs. That is exactly what the Dietary Supplement Safety Act of 2010 (DSSA) will accomplish if Big Pharma has its way.
The greatest economic challenge this country faces is how to deal with runaway disease care costs (they call it “health care” when it isn’t). What few understand is that there is no real medical cost crisis. Medical care is so expensive today because it has been so corruptly over-regulated. Disease care costs, in other words, are egregiously hyper-inflated compared to what their free market price would be.
FDA Failure, Deception and Abuse is the title of a new book that documents that disease care costs are a result of endless legislation passed by Congress that enables those in conventional medicine to earn obscene profits, while the nation’s economy collapses under the burden of outlandish prices for dangerous and minimally effective therapies.
The proposed Dietary Supplement Safety Act of 2010 is an egregious example of how this kind of insidious legislation comes into being, and how the public is deceived into thinking that Congress is seeking to “protect” them (in this case from nothing), when the real purpose of the legislation is to further enrich the entrenched drug cartel that long ago bought and paid for most of Congress and the FDA.
The Dietary Supplement Safety Act of 2010 is a blatant example of how Congress undermines free markets and decimates private sector innovation.
The encouraging news is that the numbers of dedicated supplement users are enormous.
As in the 1980s and 1990s, the majority of the public is strongly on our side. Your voice needs to be heard to usurp the predatory financial influence pharmaceutical companies wield over Congress.
1. Bronstein AC, Spyker DA, Cantilena LR Jr, Green JL, Rumack BH, Giffin SL. 2008 Annual Report of the American Association of Poison Control Centers’ National Poison Data System (NPDS): 26th Annual Report. Clinical Toxicology. 2009. 47, 911-1084.
DMAA Substance Linked To Potentially Fatal Side Effects! See bottom of the post for all the possible variations or ingredients that contain DMAA. For up-to-date information, visit the HPRC’s website and search for DMAA
The U.S. Food and Drug Administration has ordered fitness supplement companies to immediately stop selling popular bodybuilding and weight-loss products containing DMAA, because of the substance’s potentially fatal side effects.
The agency has determined DMAA which is sold as 1,3-dimethylamylamine, methylhexanamine, or geranium extract is a synthetic substance that could cause heart attacks by elevating blood pressure in users. There have been 42 public complaints about products containing DMAA, indicating it might be linked to other serious health effects including nervous system and psychiatric disorders as well as death, the agency said Friday in a news release.
Products containing DMAA were pulled from military exchange store shelves in December. The substance has fallen under increasing scrutiny since Stars and Stripes reported that DMAA was found during toxicology tests of two soldiers who suffered heart attacks and died during physical training at a base in the Southwest U.S.
Be careful and if you are taking any pre-workout supplements, READ THE LABEL!
Here is a link to a list of the pre-workout substances that contain the banned DMAA substance.
A few of the more popular substances that contain DMAA Are:
Jack3d by USPlabs
OxyELITE Pro – UPSlabs
HydroxyStim by MuscleTech
Matador Extreme Energy
NOX Pump – Dorian Yates Nutrition
In checking labels, you need to know that there are numerous terms/synonyms for DMAA. The most common ones are 1,3-dimethylamylamine; methylhexaneamine or MHA; dimethylpentylamine or DMP; 4-methylhexan-2-amine; Geranamine; and
geranium oil, extract, or stems and leaves. However, other names are also used, so we have compiled a list of various terms
that could appear on an ingredient label:
• 4-methylhexan-2-amine (IUPAC)
• C7H17N (chemical formula)
• CAS 105-41-9
• dimethylamylamine (DMAA)
• dimethylpentylamine (DMP)
• Geranamine (Proviant™)
• Geranium extract
• Geranium flower extract
• Geranium oil
• Geranium oil extract
• Geranium stems and leaves
• Methylhexaneamine (MHA)
• Pelargonium (various)
• synthetic geranium
EDITOR'S NOTE: Fortunately, this attempt to limit food supplement access by creating cost-prohibitive regulations failed — even though slipped in at a time when most were not paying attention. This will not be the last time, however, as Codex Alimentarius (the global treaty that seeks to control all food production, packaging and marketing) requires that these laws be passed and enforced in the U.S.Flying under the radar of many political pundits because it was introduced right before the Independence Day weekend, the Dietary Supplement Labeling Act of 2011 (S. 1310) is a harmless-sounding piece of legislation that could have had a devastating impact on your dietary supplements.
The bill essentially gives the FDA the power to create a black list of potentially harmful dietary ingredients. The FDA, an agency that has shown a bias against supplements throughout its history, could then use this power to arbitrarily require long warning labels on whichever supplement it chooses without being challenged by anyone.
|Under the guise of safety, congressional leaders with a deep loyalty to the pharmaceutical industry, seek to limit consumer access to food supplements with new federal laws.|
While melatonin can be bought over the counter in the United States, the normal dosage for an adult is less than half of what was present in the brownies. In the months following Lazy Cakes' release, several children who had eaten the brownies were rushed to the hospital because they had fallen into a deep sleep and could not be awakened.
According to Durbin, S. 1310 would protect consumers by warning them of dangerous ingredients in products like Lazy Cakes that market themselves as dietary supplements. But does Durbin’s bill address the Lazy Cakes problem, or is it about something more?
Fortunately, the FDA already has the power to ban Lazy Cakes as a dietary supplement, and, in fact, already has. In a letter written to Lazy Cakes manufacturer HBB, the FDA warned that Lazy Cakes are not eligible for dietary supplement protection and could be seized from store shelves.
Since the FDA already has the power to remove dangerous food from store shelves, even when sellers label the products as dietary supplements, Sen. Durbin’s bill only affects the dietary supplements that are GRAS (Generally Recognized as Safe by qualified experts under conditions of use). At best, the bill is redundant. At worst, it lays the groundwork for a full approval process for dietary supplements that would make them too expensive for most manufacturers to produce.
Banned Supplements – What’s Really Happening
Post date: 27.07.2011 12:20 AM
Your Reaction?Most of us rely on natural supplements and foods to
rejuvenate our minds and bodies and strengthen our immune system. To
imagine a life without these supplements seems rather drastic, but
unless someone takes off the blinders that the FDA is wearing so
stubbornly, this could well become a reality.
As shocking as it
sounds, the FDA is on a banning spree, and they’re taking their cues
from the EU. Number of natural supplements and traditional herbs such as
St. John’s Wort and Valerian were recently banned in UK. The EU has
also banned traditional Chinese and Indian medicines which are known to
have some very good restorative properties and can cause no harm if
taken in the right proportions.
If the FDA follows in the footsteps
of its European counterpart, chances are that many natural supplements
that we’ve been relying on heavily, especially those that were
formulated after 1994, could well be shown the door.
What the FDA is doing
story begins in 1994, when the FDA was forced to stop regulating
dietary supplements by the government by the implementation of a law
known as DSHEA. This law also required manufacturers of dietary
supplements to inform the FDA whenever they used a new ingredient in
their supplements. However, it was never quite clear how dietary
supplement manufacturers were supposed to notify the FDA, and the New
Dietary Ingredient (NDI) rules had remained an ignored subsection until
FDA has decided to implement NDI very recently, which effectively means
that all dietary supplements with new ingredients since 1994 are no
longer valid. Armed with the new implementation or enforcement of these
old rules, the FDA stands poised to virtually destroy the natural and
nutritional supplements industry.
Already banned or in the danger zone
natural supplements are already in the danger zone and are being touted
by the FDA as unsafe. The FDA went as far as to seizing labels and
threatening many companies with arrest. Some of the products that have
been deemed unsafe by the FDA are:
Probiotics – The FDA says that
manufacturers of probiotics make false claims regarding treatment or
control of possible health issues such as colds, flu, respiratory
infections, ulcers, etc.
Elderberry juice - According to the FDA,
elderberry juice falls under the category of those supplements that
wrongfully lead a person to avoid seeking legitimate treatment.
Pyridoxamine - This common form of Vitamin B6 has already gone under the hammer in 2009.
to the FDA, these nutritional supplements are harmful because they can
interfere with other drugs that people might be taking. What probably
irks most is the FDA’s assumption that it knows what’s best for the
people. Do they really?
Why the FDA is banning supplements?
answer is easy- money. If more people start using natural supplements,
they will have better immunity, and fewer people will get sick. A
healthy nation rings the death knell for pharmaceutical companies. By
implementing this ban, the FDA is trying to ensure the survival of
pharmaceutical companies at the risk of destroying the natural
supplement industry. If you know even a little about big league drug
companies, you know that they’re all about ‘curing’ diseases, and that
no one really cares about ‘preventing’ them.
On the other hand,
natural medicines, herbs, and supplements that are considered as
alternative medicine actually cost way less than their chemical
counterparts and have fewer or no side effects. However, the FDA has
chosen to ignore this important aspect and has taken a strict stance
toward natural remedies. In fact, they have started threatening
companies selling natural products, seizing some of these products from
manufacturers and threatening these practitioners with financial
penalties and injunctions.
If you think this is a conspiracy theory,
what would you say about the FDA already changing some of the NDI rules,
wherein synthetic drugs do not need any notification or approval?
you heard that right. According to the FDA, drug companies that use
synthetic copies of natural molecules are exempt from the whole
rigmarole of reporting additions of new ingredients to their products.
If this doesn’t sound like the selective enforcement of rules, then what
July 29, 2011 By 8 Comments
Greatest Threat Since FDA Tried to Turn
Nutrients into Prescription Drugs!
Nutrients into Prescription Drugs!
|Listen to William Faloon discuss the FDA’s Latest Attempt to Ban your Dietary Supplements as recorded during the recent Life Extension Scientific Advisory Board meeting|
If this proposal is enacted, many fish oil formulas and natural plant extracts will be removed from the market until so-called safety testing is done. The FDA wants each nutrient company to force-feed laboratory animals the human equivalent of up to 240,000 milligrams a day of certain fish oils. This outlandish dose will injure the test animals and give the FDA an excuse to outlaw the supplement.
How can the FDA do this? They are seeking to reclassify the natural supplements you now take as “food additives.” This gives the FDA power to mandate outrageous safety thresholds that have no relationship to the scientifically validated doses of nutrients you take every day.
Why are they doing this? Because these natural products work too well. Take curcumin as an example. It has been shown to inhibit a deadly transcription factor in cells called nuclear factor-kappa beta (NF-kB) that is responsible for immune system regulation. Over-expression of NF-kB is linked with tumor cells that resist normal cell growth and maturation, as well as inflammation.
Pharmaceutical companies want to own the exclusive rights to these kinds of plant extracts that are freely sold on the market today. They don’t want consumers to be able to obtain these biological benefits in low-cost supplements. Instead, they want to patent synthetic versions as high-priced prescription drugs!
What is being done to Stop This Travesty?
To give you an idea about how dangerous these draconian proposals are, Life Extension helped organize a conference call last week. Dozens of health freedom organizations participated and agreed to coordinate a massive consumer revolt.
The official start date of this uprising is Thursday, September 8, 2011, but you can take preliminary action today to thwart the FDA’s latest attempt to steal your supplements and make them the exclusive domain of Big Pharma.
We ask that you forward this e-mail to everyone you know so they can understand the precarious state their health will be in when the FDA bans their most effective dietary supplements.
Then, use our convenient website to e-mail letters to the White House, your Representative and two Senators by clicking on the links below:
- Send a letter to your Representative and two Senators demanding the FDA immediately withdraw their oppressive proposed guidelines pending rational discussions with those who depend on dietary supplements to protect their health and livelihood.
- Send a letter to the President’s Office of Management and Budget as the FDA’s proposed guidelines on new dietary ingredients directly conflict with an Executive Order issued July 11, 2011, that orders the FDA to streamline and repeal burdensome regulations that interfere with job creation, economic growth, and innovation.
For longer life,
“Was the government to prescribe to us our medicine and diet, our bodies would be in such keeping as our souls are now.”
—Thomas JeffersonHistorical Perspective
For those who don’t recall, the federal government came very close to transforming high-potency supplements into prescription drugs in the 1970s.
The medical establishment lobbied so hard that it was a foregone conclusion that Congress would change the law and force Americans to obtain prescriptions for many of their supplements.
No one expected the consumer backlash that overwhelmed Congress into submission.
Vitamin users inundated Congress with so many protests that the Proxmire Vitamin Bill was enacted in 1976. This bill prohibited the FDA from turning dietary supplements into “drugs” as the American Medical Association was urging.
Annual vitamin sales were less than $2 billion in the 1970s, yet Congress received more mail from angry vitamin supplement users than any other issue except the Vietnam War.
Today, Americans use over $26 billion of dietary supplements each year, so you can imagine how many angry protests Congress will hear when the public learns the FDA is trying to ban every supplement introduced after October 15, 1994.
The FDA’s proposed guidelines represent the greatest threat to health freedom since the medical establishment tried to seize control over your right to ingest food supplements. Please take action today by contacting The White House and Congress today by clicking the buttons below.